FDA 510(k) Application Details - K120495

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K120495
Device Name	Catheter, Intravascular, Diagnostic
Applicant	BOSTON SCIENTIFIC CORP. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 US Other 510(k) Applications for this Company
Contact	YUMI WACKERFUSS Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2012
Decision Date	05/21/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review